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Astellas Reports First Quarter FY2017 Financial Results

Published: Jul 28, 2017

Sales (-4.5%), core operating profit (-30.7%) and core profit (-22.7%)
for the period decreased due to the impacts such as the transfer of
the global dermatology business in April 2016 and the transfer of
long-listed products in Japan in April 2017.

Astellas continues to create solid and resilient growth over the
mid-to-long term.

TOKYO--(BUSINESS WIRE)--Astellas Pharma Inc. (TOKYO:4503)(President and CEO: Yoshihiko Hatanaka,
“Astellas”) today announced the financial results for the first quarter
of fiscal year 2017 (“FY2017”), ending March 31, 2018.

“Financial results for the first quarter of FY2017 were in line
with our expectations and the previously announced consolidated
forecasts. Although some development programs were discontinued, the
rest of our development activities are progressing steadily, and the
acquisition of Ogeda expanded Astellas’ late-stage clinical pipeline
including fezolinetant,” said Yoshihiko Hatanaka, president and CEO,
Astellas. “We remain committed to creating innovative medical solutions
and delivering value for patients and all stakeholders, as we continue
to advance our strategic plan through maximizing the product value,
creating innovation and pursuing operational excellence.”

Sales in the first three months of FY2017 decreased by 4.5% compared to
those in the corresponding period of the previous fiscal year
(“year-on-year”) to ¥322.6 billion due to impacts such as the transfer
of the global dermatology business in April 2016 and the transfer of
long-listed products in Japan in April 2017.

Oncology franchise

Sales of XTANDI® increased by 5.8% year-on-year to ¥67.9
billion. Sales in the United States (“U.S.”) decreased, but sales grew
steadily in Japan, the Americas excluding the U.S., EMEA1,
Asia and Oceania regions.

Sales of Prograf® (tacrolomis) remained largely unchanged
year-on-year to ¥49.4 billion, and continued to grow in the EMEA, Asia
and Oceania regions.

Other new and key products

In the Japanese market, continued growth was achieved with products such
as Celecox® (celecoxib) for the treatment of inflammation and
pain, Symbicort® (budesonide and formoterol fumarate
dihydrate) for the treatment of bronchial asthma, Suglat®
(ipragliflozin) for the treatment of type 2 diabetes, and Cimzia®
(certolizumab pegol) for the treatment of adult patients with rheumatoid
arthritis. Accordingly total sales of these four products increased by
4.6% year-on-year to ¥27.7 billion. Meanwhile, we have been steadily
working to penetrate the market with our launches of Repatha®
(evolocumab) for the treatment of hypercholesterolemia in April 2016 and
of LINZESS® (linaclotide) for the treatment of irritable
bowel syndrome with constipation in March 2017. In the Americas, sales
of azole antifungal CRESEMBA® (isavuconazonium sulfate) grew.

(Billions of yen)

Q1 FY2016

Q1 FY2017

Change

Oncology franchise

79.1

81.8

+3.4%

XTANDI®

64.2

67.9

+5.8%

Urology OAB franchise

54.0

51.8

-4.0%

Vesicare®

30.4

24.6

-19.2%

Betanis® / Myrbetriq®
/ BETMIGA®

23.6

27.2

+15.6%

Transplantation franchise

49.4

49.4

+0.0%

Sales by Region2

Sales in Japan, the Americas and EMEA decreased, while sales in Asia and
Oceania increased. As for the Japanese market, sales decreased by 7.5%
year on year to ¥106.1 billion yen largely due to the impact of
transferring 16 long-listed products in April 2017, and the introduction
of generics for Micardis® (telmisartan) for the treatment of
hypertension during the first quarter of FY2017. Meanwhile in EMEA,
sales decreased due to the impact of transferring the dermatology
business in April 2016, yet sales showed an increase when calculated
excluding this impact.

FY2017 Guidance

The company's business forecasts for FY2017 remain unchanged from the
consolidated full-year business forecasts announced in April 2017.

Strategic Quarterly Highlights

Astellas continues to create sustainable growth over the mid-to-long
term through the pursuit of three main strategies – “Maximizing the
Product Value,” ” Creating Innovation” and “Pursuing Operational
Excellence.” The company achieved multiple accomplishments as outlined
below.

Maximizing the Product Value

Continued to maximize the growth of the Oncology franchise centered on
XTANDI® and the Urology OAB franchise including Vesicare®
and Betanis® / Myrbetriq® / BETMIGA®
with new launches across various countries and growth in sales.

Creating Innovation

Completed the acquisition of Ogeda SA in May 2017.

Announced the inauguration of “Alliance Station” with the aim of
realizing advanced medical treatments with Kyoto University in June
2017.

The following lists the main development advances achieved during the
first quarter of FY2017:

Submitted an application for marketing approval of a combination drug
of sitagliptin phosphate hydrate and ipragliflozin L-Proline for the
treatment of type-2 diabetes in Japan in May 2017.

Submitted a supplemental new drug application for mirabegron for the
use in combination with solifenacin succinate for the treatment of OAB
in the U.S. in June 2017.

NOTE: For further information on the results, please refer to the
reference documents: Financial Results, Supplementary Documents,
Overview of R&D Pipeline and Presentation Material for Information
Meeting available on the Astellas website.

(1) EMEA: Europe, the Middle East and Africa(2) Sales by Region:
based on location of sellers

About AstellasAstellas Pharma Inc., based in Tokyo, Japan,
is a company dedicated to improving the health of people around the
world through the provision of innovative and reliable pharmaceutical
products. We focus on Urology, Oncology, Immunology, Nephrology and
Neuroscience as prioritized therapeutic areas while advancing new
therapeutic areas and discovery research leveraging new
technologies/modalities. We are also creating new value by combining
internal capabilities and external expertise in the medical/healthcare
business. Astellas is on the forefront of healthcare change to turn
innovative science into value for patients. For more information, please
visit our website at www.astellas.com/en.

Cautionary NotesIn this press release, statements made with
respect to current plans, estimates, strategies and beliefs and other
statements that are not historical facts are forward-looking statements
about the future performance of Astellas. These statements are based on
management’s current assumptions and beliefs in light of the information
currently available to it and involve known and unknown risks and
uncertainties. A number of factors could cause actual results to differ
materially from those discussed in the forward-looking statements. Such
factors include, but are not limited to: (i) changes in general economic
conditions and in laws and regulations, relating to pharmaceutical
markets, (ii) currency exchange rate fluctuations, (iii) delays in new
product launches, (iv) the inability of Astellas to market existing and
new products effectively, (v) the inability of Astellas to continue to
effectively research and develop products accepted by customers in
highly competitive markets, and (vi) infringements of Astellas’
intellectual property rights by third parties.Information about
pharmaceutical products (including products currently in development)
which is included in this press release is not intended to constitute an
advertisement or medical advice.